“The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obese) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).”

The FDA went on to say that Qsymia should not be used during pregnancy, as topiramate, one of the two components of the drug, can cause harm to the fetus, increasing the risk of oral clefts during the first trimester. Topiramate, which is also known as Topamax, is an anti-convulsant and is used to treat seizures in people who have epilepsy.

The second component of the drug, the diet medication phentermine, is used for a limited period of time to speed weight loss in overweight people who are exercising and eating a low-calorie diet, according to the National Institutes of Health (NIH).

Other side effects of the drug include tingling of the hands and feet, dizziness, insomnia, constipation, altered taste sensation, and dry mouth.

Qsymia is the second prescription weight-loss pill to be approved this year. The first, Belviq, was approved on June 27. Patients using Qsymia experienced more dramatic weight loss than those taking Belviq. With Belviq, patients dropped from 220 to 207 pounds; on Qsymia, patients lost 10 more pounds, dropping from 227 to 204.

Qsymia will be available for purchase in the fourth quarter of this year.